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Abstract:  The chemical stability of hydromorphone hydrochloride in patient–controlled analgesia injectors was studied for 34 weeks at different temperatures. The sterility of the solution was also monitored at the end of 16-week storage. For the determination of stability of hydromorphone, five groups of six patient–controlled analgesia injectors containing hydromorphone solutions of 0.2 mg/mL (6 mg of drug solution in 30 mL 0.9% normal saline) sealed with plastic tip caps were stored at 5ºC in refrigerator, 20ºC on benchtop, 20ºC in dark, 35ºC in dark, and 50ºC in dark. Chemical stability was determined throughout a storage period of 34 weeks using high performance liquid chromatography. Sterility test was also performed at 16 weeks. Hydromorphone solutions stored in different conditions up to 34 weeks remained clear and free of visible precipitation throughout the study. After 8 weeks of storage in the patient–controlled analgesia injectors in different temperature conditions, the concentrations of hydromorphone in a

Related Keywords: Dristi Khondkar, PhD, Poonam Chopra, MS, John P. McArter, PharmD, Joseph A. Rosen, CPhT, S. Kevin Li, PhD, hydromorphone hydrochloride, stability, patient-controlled analgesia, analgesic, pain control, storage, parenteral adminstration, stress test, sterility testing

Related Categories: PAIN MANAGEMENT, PARENTERALS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, STERILE PREPARATIONS, QUALITY CONTROL

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